A prospective, randomized, multicenter comparative study of clinafloxacin versus a ceftriaxone-based regimen in the treatment of hospitalized patients with community-acquired pneumonia

In an open-label, phase 3, randomized, multicenter study, clinafloxacin (20 0 mg/d) was compared to ceftriaxone (2 g/d; with or without erythromycin) i n 527 patients with acute community-acquired bacterial pneumonia (CAP). Pri mary efficacy parameters were clinical cure rate and microbiologic eradicat ion rates (by pathogen and by patient) determined 5-9 d post-therapy (test of cure; TOC). Clinical cure rates at TOC for the 2 treatment groups were e quivalent in the intention-to-treat (clinafloxacin 79.3, ceftriaxone 78.6%) , clinically evaluable (clinafloxacin 88.1, ceftriaxone 85.0%), modified in tention-to-treat (clinafloxacin 82.6, ceftriaxone 86.9%) and microbiologica lly evaluable populations (clinafloxacin 86.2, ceftriaxone 86.2%). Microbio logic eradication rates cre similar in the 2 treatment groups. Both drugs w ere tolerated. Treatment of hospitalized CAP patients with clinafloxacin is a reasonable choice, especially when a resistant pathogen is anticipated.